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NCT06558591Not yet recruiting

Feasibility and Potential Impact of an Individualized Exercise Program Via a Telerehabilitation Device in Chronic Patients: A Pilot Study

Source: ClinicalTrials.gov · Last updated 16 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

Exercise Rehabilitation (ER) is widely used and effective in the treatment of chronic diseases; however, patients do not adhere to ER programs. Tele-rehabilitation is effective and often used to support and improve patient adherence. Thus, the ADEPINA device could be a promising solution for the individualized management of patients by their therapists. The aim of the study will be: a) To assess functional improvement, measured by the 6-minute walk test (6MWT) after the 12 weeks ER program in people with chronic disease. Additionally, the study will assess the individualized program' adherence and his effect on patients' physical fitness and quality of life. Methods: Fifty patients will follow individualized ER sessions to their patients (with chronic diseases) using the ADEPINA device, 2 to 3 times per week for 12 weeks. At the end of the intervention, the investigator will assess patients' lower limb strength (with sit to stand test), dynamic balance (Timed up and go test), patients' adherence to the ER program by evaluating the usage time of the system by participants, the treatment credibility and participant expectations for improvement will be assessed with the French version of the Credibility and Expectancy Questionnaire. The investigator will also evaluate the patients' quality of life (using the "World Health Organization Quality of Life" (WHOQOL) scale) at the beginning and end of the intervention. Discussion: This interventional pilot study could have positive impacts for participants and explore gaps in the current literature regarding the individualized telerehabilitation program' feasibility.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
50 (estimated)
First submitted
13 Jul 2024
Start date
1 Jan 2025
Primary completion date
31 Dec 2026
Lead sponsor
Limoges University
NCT number
NCT06558591

What you commit to

  • Study type: Interventional
  • Planned participants: 50
  • From 1 Jan 2025 to the primary completion date, 31 Dec 2026
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

  • Be a physiotherapist or kinesiologist working in the public sector, private sector, or in a mixed capacity,
  • Have been graduated for at least one year,
  • Conduct ER program with chronic patients and provide written consent.
  • Be 18 years of age or older,
  • Be able to walk with or without assistives devices
  • Be capable of giving informed consent,
  • Be registered with the French health social security system,
  • Be under the care of a rehabilitation exercise professional.
    • Non-inclusion criteria for patients :
  • Have an intolerance or inability to use digital tools,
  • Have a cognitive impairment,
  • Have contraindications to physical activity (unstable diabetes, unstable hypertension, unstable angina, intracardiac thrombus).

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.